BACKGROUNDDespite its recognised toxicity, antimonial therapy continues to be the
first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional
administration of meglumine antimoniate (MA) represents an alternative that
could reduce the systemic absorption of the drug and its side effects.OBJECTIVESThis study aims to validate the standard operational procedure (SOP) for the
intralesional infiltration of MA for CL therapy as the first step before the
assessment of efficacy and safety related to the procedure.METHODSThe SOP was created based on 21 trials retrieved from the literature, direct
monitoring of the procedure and consultation with experts. This script was
submitted to a formal computer-aided inspection to identify readability,
clarity, omission, redundancy and unnecessary information (content
validation). For criterion and construct validations, the influence of
critical condition changes (compliance with the instructions and
professional experience) on outcome conformity (saturation status
achievement), tolerability (pain referred) and safety (bleeding) were
assessed.FINDINGSThe median procedure length was 12 minutes and in 72% of them, patients
classified the pain as mild. The bleeding was also classified as mild in
96.6% of the procedures. Full compliance with the SOP was observed in 66% of
infiltrations. Despite this, in 100% of the inspected procedures, lesion
saturation was observed at the end of infiltration, which means that it
tolerates some degree of modification in its execution (robustness) without
prejudice to the result.CONCLUSIONSThe procedure is reproducible and can be used by professionals without
previous training with high success and safety rates.